Events

Safety Alert for Coiled Tube Infusors

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter Healthcare Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-06-05
  • Event Date Posted
    2013-06-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130605a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: baxter healthcare coiled tube infusors medical device manufacturer, baxter healthcare ltd, has issued a medical device safety alert concerning the coiled tube infusors [product codes: 2c1071kjp, 2c1075kjp, 2c1976kj]. the affected products were manufactured between november 2008 through september 2009. due to an increase in complaints for leaks at the distal male luer and luer cap, baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the luer. complaint rates for leaks have since decreased. baxter wants to ensure that no affected product remains in the field. leakage at the connection of the blue winged cap and the distal male luer presents the potential for delay/interruption of therapy and exposure to hazardous solutions. the manufacturer requests users to locate and return the affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 jun 2013.

Device

Coiled Tube Infusors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Healthcare Coiled Tube Infusors
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd